Cleared Traditional

K043371 - BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER

K043371 is an FDA 510(k) clearance for BIOMERIX VASCULAR OCCLUSION DEVICE AND ..., manufactured by Biomerix Corporation. The device is a Class 2 Cardiovascular device with product code KRD cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K043371 · Biomerix Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
57d
Days
Class 2
Risk

K043371 is an FDA 510(k) clearance for the BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER. Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by Biomerix Corporation (Rockville, US). The FDA issued a Cleared decision on February 3, 2005 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3300 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biomerix Corporation devices

FDA 510(k) Submission Details - K043371

510(k) Number K043371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2004
Decision Date February 03, 2005
Days to Decision 57 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 125d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRD Device Classification - Class 2, Special Controls

Product Code KRD Device, Vascular, For Promoting Embolization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - KRD Device, Vascular, For Promoting Embolization

All 98
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K043371.
FIBERED IDC OCCLUSION SYSTEM
K060078 · Boston Scientific Corporation · Jan 2006
MREYE EMBOLIZATION COIL
K052834 · Cook, Inc. · Nov 2005
CONCENTRIC EMBOLIC PEARLS
K050470 · Concentric Medical, Inc. · May 2005
INTERLOCKING DETACHABLE COIL SYSTEM (IDC)
K040342 · Boston Scientific Corp · Apr 2004
CONTOUR SE MICROSPHERES
K034068 · Boston Scientific Corp · Mar 2004
FLIPPER DETACHABLE EMBOLIZATION COIL
K993455 · Cook, Inc. · Jan 2000